UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.goV
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`APPLICATION NO.
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`F ING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`CONF {MATION NO.
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`10/500,354
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`06/30/2004
`
`Masayo Higashiyama
`
`2004_1016A
`
`2612
`
`WENDEROTH,LIND&PONACK,L.L.P.
`1030 15th Street, N.W.,
`Suite
`East
`
`FRAZIER, BARBARA s
`ART UNIT
`PAPER \1Ul\/IBER
`1611
`
`04/09/2010
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on aboVe—indicated "Notification Date" to the
`following e—mail address(es):
`ddalecki @Wender0th.c0m
`e0a@ Wender0th.c0m
`
`PTOL—90A (Rev. 04/07)
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`
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`MYLAN Ex. 1025, Page 1
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`

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`Office Action Summary
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`Application No.
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`App|icant(s)
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`10/500,354
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`HIGASHIYAMA, MASAYO
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`Examine,
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`BARBARA FRAZIER
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`A,, Unit
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`1611 -
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`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE Q MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`- Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
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`Status
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`1)IXI Responsive to communication(s) filed on 08 October 2009.
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`2a)I:I This action is FINAL.
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`2b)IXI This action is non-final.
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`3)I:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under Ex parte Quayle, 1935 C.D. 11, 453 O.G. 213.
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`Disposition of Claims
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`4)IXI C|aim(s) 1-10 12 and 13 is/are pending in the application.
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`4a) Of the above c|aim(s)
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`is/are withdrawn from consideration.
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`5)I:I C|aim(s) j is/are allowed.
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`6)IXI C|aim(s) 1-10 12 and 13 is/are rejected.
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`7)I:I C|aim(s) j is/are objected to.
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`8)I:I C|aim(s) j are subject to restriction and/or election requirement.
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`Application Papers
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`9)I:I The specification is objected to by the Examiner.
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`10)I:I The drawing(s) filed on
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`is/are: a)I:I accepted or b)I:I objected to by the Examiner.
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`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
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`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
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`Priority under 35 U.S.C. § 119
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`12)IXI Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
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`a)IZ All
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`b)I:I Some * c)I:I None of:
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`1.IXI Certified copies of the priority documents have been received.
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`2.I:I Certified copies of the priority documents have been received in Application No.
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`3.I:I Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
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`* See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`1) D Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson's Patent Drawing Review (PTO-948)
`3) |:| Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date
`.
`U.S. Patent and Trademark Office
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`4) D Interview Summary (PTO-413)
`Paper N0(S)/IVI3” Data L
`5) I:I Notice of informal Patent Application
`6) D Other:
`.
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`PTOL-326 (Rev. 08-06)
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`OfficeAction Summary
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`MYLAN Ex. 1025, Page 2
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`

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`Application/Control Number: 10/500,354
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`Page 2
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`Art Unit: 1611
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`DETAILED ACTION
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`Status of Claims
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`1.
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`Claims 1-10, 12, and 13 are pending in this application. Claim 11 stands
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`canceled.
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`2.
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`3.
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`Addition of new claims 12 and 13 is acknowledged.
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`Claims 1-10, 12, and 13 are examined.
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`Claim Rejections - 35 USC § 112
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`4.
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`The rejection of claims 1-10 under 35 U.S.C. 112, first paragraph is withdrawn in
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`view of Applicant’s amendment to claim 1.
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`Claim Rejections - 35 USC § 103
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`5.
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`The text of those sections of Title 35, U.S. Code not included in this action can
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`be found in a prior Office action.
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`6.
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`The previous rejection of claims 1-10 under 35 U.S.C. 103(a) as being
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`unpatentable over Kita et (US Patent 6,307,052), Stevenson (US Patent 4,053,628) is
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`modified as follows:
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`7.
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`Claims 1-10, 12, and 13 are rejected under 35 U.S.C. 103(a) as being
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`unpatentable over Stevenson (US Patent 4,053,628) in view of Kita et al (US Patent
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`6,307,052).
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`MYLAN Ex. 1025, Page 3
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`Application/Control Number: 10/500,354
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`Page 3
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`Art Unit: 1611
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`The claimed invention is drawn to an aqueous liquid preparation comprising, in
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`an aqueous solution, (+)—(S)—4—[4—[(4—chlorophenyl)(2—pyridyl)methoxy]piperidino]butyric
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`acid (i.e., bepotastine) or a pharmacologically acceptable acid addition salt thereof, and
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`a water—soluble metal chloride in a light—stabilizing effective amount of 0.2 w/v% or more
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`(see claim 1).
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`Stevenson et al teach substantially clear, sterile aqueous solutions indicated for
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`the treatment of conditions of the eye and the nose (abstract). The compositions may
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`contain conventional excipients, such as sodium chloride (col. 2, lines 61-62) in
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`amounts preferably less than 5% w/v (col. 3, lines 4-6); amounts of sodium chloride of
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`0.56% w/v and 0.42% w/v are exemplified (col.s 5 and 6, Examples 1 and 3). The
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`compositions may also contain additional therapeutically useful compounds, such as
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`antihistamine (col. 3, lines 7-13).
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`Stevenson et al do not specifically teach that the antihistamine may be
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`bepotastine.
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`Kita et al teach that the benzenesulfonic acid salt or benzoic acid salt of (S)—4—[4—
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`[(4—chlorophenyl)(2—pyridyl)methoxy]piperidino]butanoic acid (i.e., bepotastine) is
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`excellent in antihistaminic activity and antiallergic activity, has little hygroscopicity and
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`excellent in physicochemical stability, so that it is particularly suitable compound as a
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`medicine (col. 1, lines 10-22).
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`It would have been obvious to a person having ordinary skill in the art at the time
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`the invention was made to select bepotastine as the antihistamine in the composition of
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`Stevenson et al; thus arriving at the claimed invention. One skilled in the art would be
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`MYLAN Ex. 1025, Page 4
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`Application/Control Number: 10/500,354
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`Page 4
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`Art Unit: 1611
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`motivated to do so, with a reasonable expectation of success, because bepotastine
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`provides the benefits of having excellent antihistaminic activity, little hygroscopicity, and
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`excellent physicochemical stability, as taught by Kita et al.
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`Regarding the limitations, “a water—soluble metal chloride in a light—stabilizing
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`effective amount of 0.2 w/v% or more” (claim 1), “sodium chloride at not less than 0.2
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`w/v% and not more than 0.8 w/v% in a light—stabilizing effective amount” (claim 10), and
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`“light—stabilized with a water—soluble metal chloride at not less than 0.2 w/v% (claim 13),
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`Stevenson et al exemplify amounts of sodium chloride of 0.56% w/v and 0.42% w/v
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`(col.s 5 and 6, Examples 1 and 3). These amounts would necessarily be a light-
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`stabilizing effective amount, as evidenced by Applicant’s specification. Since
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`concentrations of sodium chloride of 0.56% and 0.42%, as taught by the Stevenson et
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`al, overlaps with the amount of sodium chloride disclosed by applicant as being a "light—
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`stabilizing effective amount (specification, page 8, lines 6-15, including Table 1), one
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`would reasonably expect that the sodium chloride component of the aqueous liquid
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`preparations encompassed by the prior art, wherein said sodium chloride is present in
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`an amount of 0.2% or more (e.g. 0.56%) would also be a light—stabilizing effective
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`amount, absent objective evidence to the contrary.
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`Regarding claims 2, 3, and 12, Stevenson et al exemplify sodium chloride as an
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`excipient present in the composition, in amounts of 0.56% w/v and 0.42% w/v (col.s 5
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`and 6, Examples 1 and 3), which are within Applicant’s range.
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`Regarding claim 4, Stevenson et al teach that amounts of additional compounds
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`may be present at a concentration of from about 0.05 to 0.6% w/v (col. 3, lines 32-34).
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`MYLAN Ex. 1025, Page 5
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`Application/Control Number: 10/500,354
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`Page 5
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`Art Unit: 1611
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`This range overlaps that of the claimed invention, and one skilled in the art would be
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`motivated to manipulate the amount of antihistamine present in the composition from
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`within said ranges by routine experimentation, in order to optimize antihistaminic activity
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`of the resultant composition.
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`Regarding claims 5 and 6, Kita et al teach the benzenesulfonic acid salt of
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`bepotastine (col. 1, lines 11-13).
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`Regarding claim 7, Stevenson et al teach that the preferred pH for maximum
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`stability is from 4 to 7.5 (col. 3, lines 2-4), which is comparable to Applicant's range.
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`Regarding claims 8 and 9, Stevenson et al teach that the composition may be
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`administered to the eye or the nose, and exemplify eye drops and nasal spray
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`(Examples 1-3). Since a "nasal spray" is comprised of droplets when sprayed into the
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`nose, it reasonably reads on "nasal drop".
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`Response to Arguments and Declaration
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`8.
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`Applicant's arguments filed 10/8/09 have been fully considered but they are not
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`persuasive.
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`In response to Applicant’s arguments regarding differences between the
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`antihistamine compounds exemplified in Stevenson et al and the antihistamine taught
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`by Kita et al (i.e., bepotastine), it is noted that all of the compounds taught fall within the
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`class of antihistamines, and therefore are functionally equivalent to one another.
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`Furthermore, Stevenson et al do not limit their invention to the antihistamines named,
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`but rather teach that antihistamines may be added, and only teach Antazoline or
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`MYLAN Ex. 1025, Page 6
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`Application/Control Number: 10/500,354
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`Page 6
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`Art Unit: 1611
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`diphenhydramine as examples. Disclosed examples and preferred embodiments do not
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`constitute a teaching away from a broader disclosure or nonpreferred embodiments.
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`In
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`re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Additionally, one skilled in the art
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`would be motivated to select bepotastine as the antihistamine, due to its excellent
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`activity as an antihistamine as well as its stability, as taught by Kita et al.
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`In response to Applicant’s arguments regarding the light instability problem
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`associated with bepotastine, it is noted that the presence of sodium chloride in the
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`compositions of Stevenson et al is already exemplified (Examples 1 and 3), in light-
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`stabilizing effective amounts, and therefore the sodium chloride of the composition of
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`Stevenson et al would necessarily provide a light—stabilizing effect to the added
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`components, including antihistamines.
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`“[T]he discovery of a previously unappreciated property of a prior art composition,
`or of a scientific explanation for the prior art’s functioning, does not render the old
`composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d
`1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use,
`new function or unknown property which is inherently present in the prior art does not
`necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ
`430, 433 (CCPA 1977). There is no requirement that a person of ordinary skill in the art
`would have recognized the inherent disclosure at the time of invention, but only that the
`subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva
`Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).
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`In response to applicant's argument that the examiner's conclusion of
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`obviousness is based upon improper hindsight reasoning, it must be recognized that
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`any judgment on obviousness is in a sense necessarily a reconstruction based upon
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`hindsight reasoning. But so long as it takes into account only knowledge which was
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`within the level of ordinary skill at the time the claimed invention was made, and does
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`not include knowledge gleaned only from the applicant's disclosure, such a
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`MYLAN Ex. 1025, Page 7
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`Application/Control Number: 10/500,354
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`Page 7
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`reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA
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`1971).
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`In response to Applicant’s arguments regarding the Declaration, it is noted that
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`the Declaration has been considered but is not deemed persuasive for overcoming the
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`rejection because the light—stabilizing effective amounts of sodium chloride are
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`exemplified in Stevenson et al, and thus the sodium chloride of the composition of
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`Stevenson et al would necessarily provide a light—stabilizing effect to the added
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`components, including antihistamines, for reasons stated above.
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`No claims are allowed at this time.
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`Conclusion
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to BARBARA FRAZIER whose telephone number is
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`(571)270-3496. The examiner can normally be reached on Monday—Thursday 9am-4pm
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`EST.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Sharmila Landau can be reached on (571)272-0614. The fax phone
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`number for the organization where this application or proceeding is assigned is 571-
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`273-8300.
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`MYLAN Ex. 1025, Page 8
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`Application/Control Number: 10/500,354
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`Page 8
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`Art Unit: 1611
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`Information regarding the status of an application may be obtained from the
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`Patent Application Information Retrieval (PAIR) system. Status information for
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`published applications may be obtained from either Private PAIR or Public PAIR.
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`Status information for unpublished applications is available through Private PAIR only.
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`For more information about the PAIR system, see http://pair—direct.uspto.gov. Should
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`you have questions on access to the Private PAIR system, contact the Electronic
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`Business Center (EBC) at 866-217-9197 (toll—free). If you would like assistance from a
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`USPTO Customer Service Representative or access to the automated information
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`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-’| 000.
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`BSF
`
`/Ashwin Mehtal
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`Primary Examiner, Technology Center 1600
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`
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`MYLAN Ex. 1025, Page 9